0836-major(100c/1000c)

0836-major(100c/1000c)
SPL v2
SPL
SPL Set ID d4ec6dfd-61b0-7153-e053-2995a90ad88f
Route
ORAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Anhydrous Lactose Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: CPC;836 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-11-02
Description

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 50 mg

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing
Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and over Take 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
Questions?

Questions or comments? (800) 616-2471

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

Other Information
  • Store at room temperature, USP.
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose
Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Or Pharmacist

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Package Label.principal Display Panel

Active Ingredient (in Each Banded Capsule)

Diphenhydramine Hydrochloride 50 mg

Structured Label Content

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing
Purpose

Antihistamine

Warnings (WARNINGS)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions
  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours
adults and children 12 years of age and over Take 1 capsule (50 mg)
children under 12 years of age ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
Questions?

Questions or comments? (800) 616-2471

Distributed By (Distributed by)

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

Other Information
  • Store at room temperature, USP.
  • Do not use if either capsule band or imprinted safety seal under cap is broken or missing
  • Protect from moisture
  • Contains lactose
Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Active Ingredient (in Each Banded Capsule) (Active Ingredient (in each banded capsule))

Diphenhydramine Hydrochloride 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.861718 · Updated: 2026-03-14T23:05:53.122655